Systems and methods related to collection of biological fluids

ABSTRACT

Collection of biological fluids. At least some of the example embodiments are polymeric sleeves including: an elongate body that defines a first end, a second end opposite the first end, and a longitudinal central axis; a main passageway through the elongate body parallel to the central axis, the main passageway extends from the first end to the second end, and the main passageway defines a first aperture on the first end and a second aperture on the second end; a first member suspended over the first aperture on the first end, the first member defines a first initial passageway parallel to the main passageway, and the first member and first end define an interior volume; and a first vent opening defined in part by the first member, the first vent opening distinct from the passageways, and the first vent opening fluidly couples the interior volume to atmosphere pressure.

BACKGROUND

In recent years there have many advancements in devices for stimulationand collection of biological fluids, particularly seminal fluids. Forexample, FLESHLIGHT® brand products are devices that aid in stimulationand collection of seminal fluids through ejaculation. Many such productsvisually mimic genitalia, and also attempt to simulate the feel ofcopulation.

Recent studies have found that prostate health in human males may berelated to frequency of ejaculation. In particular, infrequentejaculation can lead to swelling of the prostate, known as congestiveprostatitis, and may also increase the cancer risk in human males. Somemedical sources suggest an ejaculation frequency of three to four timesper week ensures good prostate health and reduces cancer risk. One studyfound a 14% lower lifetime prostate cancer rate for men who ejaculatebetween 13 and 20 times per month, and an upwards of 33% lower lifetimeprostate cancer risk for men who ejaculate 21 times or more each month.Devices for stimulation and collection of seminal fluids may aid inachieving higher ejaculations rates among men, particularly theunmarried and long-married.

Beyond the prostate health effects of ejaculation, devices forstimulation and collection of seminal fluids through ejaculation mayalso assist in reversing desensitization issues. That is, repeatedmasturbatory stimulation of the penis using the hand or rough cloth canlead to desensitization of the penis, particularly in the absence oflubrication. Desensitization can then result in erectile dysfunctionduring copulation. Use of properly lubricated devices designedspecifically for the stimulation and collection of seminal fluid mayhelp reverse the desensitization issues, and thus reduce the occurrenceof erectile dysfunction related to desensitization issues.

Any improvement in devices for stimulation and collection of seminalfluid, in view of the positive health benefits, would be beneficial.

BRIEF DESCRIPTION OF THE DRAWINGS

For a detailed description of exemplary embodiments, reference will nowbe made to the accompanying drawings in which:

FIG. 1 shows a perspective view of system in accordance with at leastsome embodiments;

FIG. 2 shows a cross-sectional elevation view in accordance with atleast some embodiments;

FIG. 3 shows a perspective, partial cut-away view, in accordance with atleast some embodiments;

FIG. 4 shows a cross-sectional elevation view in accordance with atleast some embodiments;

FIG. 5 shows a perspective view of a mold assembly in accordance with atleast some embodiments;

FIG. 6 shows a perspective view of lower mold component in accordancewith at least some embodiments;

FIG. 7 shows a perspective view of an upper side of a first disk memberin accordance with at least some embodiments;

FIG. 8 shows a perspective view of a lower side of a first disk memberin accordance with at least some embodiments;

FIG. 9 shows a perspective view of an upper side of a second disk memberin accordance with at least some embodiments;

FIG. 10 shows a perspective view of a lower side of the second diskmember in accordance with at least some embodiments;

FIG. 11 shows a perspective view of a mold system in accordance with atleast some embodiments;

FIG. 12 shows a cross-sectional elevation view of a mold assembly inaccordance with at least some embodiments;

FIG. 13 shows a perspective view of a system in accordance with at leastsome embodiments; and

FIG. 14 shows a method in accordance with at least some embodiments.

NOTATION AND NOMENCLATURE

Certain terms are used throughout the following description and claimsto refer to particular system components. As one skilled in the art willappreciate, different companies may refer to a component by differentnames. This document does not intend to distinguish between componentsthat differ in name but not function.

In the following discussion and in the claims, the terms “including” and“comprising” are used in an open-ended fashion, and thus should beinterpreted to mean “including, but not limited to . . . ” Also, theterm “couple” or “couples” is intended to mean either an indirect ordirect connection. Thus, if a first device couples to a second device,that connection may be through a direct connection or through anindirect connection.

“Bifurcate” shall mean that an area or volume is divided, but shall notspeak to relative sizes of the divided areas or volumes.

“Removably coupled” shall mean that a first device couples to seconddevice in such a way that the first device can be mechanically separatedfrom the first device without the use of tools, without cutting eitherthe first device or the second device, and without full or partialdestruction of either the first device or the second device.

“Mold surface” shall mean any exposed surface area within the lower moldcomponent (which lower mold component may be referred as a tool ortooling), whether or not the exposed surface directly abuts a diskmember or defines a cavity or channel.

“Over,” “above,” and “below” are relative terms related to the variousdevices described herein. In relation to a seminal fluid collectiondevice, the terms “over,” “above,” and “below” shall be in reference toa seminal fluid collection device with the insertion end held upwardlyfor viewing. In relation to a mold system, the terms “above” and “below”shall be in reference to mold components stacked in relation to gravity.

DETAILED DESCRIPTION

The following discussion is directed to various embodiments of theinvention. Although one or more of these embodiments may be preferred,the embodiments disclosed should not be interpreted, or otherwise used,as limiting the scope of the disclosure, including the claims. Inaddition, one skilled in the art will understand that the followingdescription has broad application, and the discussion of any embodimentis meant only to be exemplary of that embodiment, and not intended tointimate that the scope of the disclosure, including the claims, islimited to that embodiment.

The various embodiments are directed to systems, and related methods, ofstimulation of and collection of biological fluids, particularly seminalfluid. The various example systems were developed in the context ofdevices for use by human males, and thus the description that follows isbased on the developmental context; however, the systems and methods mayfind other uses, such as veterinary uses (e.g., horses, dogs), and thusthe developmental context shall not be viewed as a limitation as to thescope of the applicability of the devices.

FIG. 1 shows a perspective view of system 100 in accordance with atleast some embodiments. In particular, the system 100 comprises apolymeric sleeve 102 at least partially disposed within an interiorvolume of an outer cover 104 of rigid material, such as plastic. In theview of FIG. 1, only the insertion end 106 of the polymeric sleeve 102is visible, as the balance of the polymeric sleeve resides within theouter cover 104. The polymeric sleeve 102 may be made of a thermoplasticelastomer gel (TPE) of low durometer rating, or other material, such assilicon, polyvinyl chloride (PVC), or elastomeric rubber. The system 100may further comprise a cover or lid 108 that defines an inside diameterD2 slightly larger than the outside diameter of the D1 of the insertionend 106 of the polymeric sleeve 102 such that, when not in use, the lid108 may be telescoped over the insertion end 106 and couple to the outercover 104. The lid 108 may, for example, protect the insertion end 106from damage when not in use. The system 100 may further comprise asecond cap or lid 110 that couples to the outer cover 104 opposite thelid 108. The lid 110 may act, in some cases and in conjunction withother features of the outer cover 104, as a controllable vent mechanismduring use (discussed more below).

The insertion end 106 of the example system of FIG. 1 comprises a mainaperture 112 which leads to a main passageway (the main passageway notvisible in FIG. 1, but discussed more below). Suspended over the mainaperture 112 is a first flange member 114 that defines an initialpassageway 116. In the example system, the initial passageway 116 iscoaxial with the main passageway, and both the initial passageway 116and main passageway are coaxial with the longitudinal central axis 118of the polymeric sleeve 102. In other systems, however, the initialpassageway 116 may be offset from the main passageway, and one or boththe initial passageway 116 and the main passageway may be offset (and/ornon-parallel) to the longitudinal central axis 118 of the polymericsleeve 102.

Still referring to FIG. 1, the flange member 114 is supported in theexample system by three stanchion portions 120A, 120B, and 120C. As willbe discussed more thoroughly below, the entire polymeric sleeve 102(including the flange member and stanchion portions) may be created froma single molding of polymeric material, and thus while the flange member114 and the stanchion portions 120 are separately named for ease ofdiscussion, the separate naming convention shall not obviate that theseparately named components are actually a single, continuous piece ofpolymeric material. The stanchion portions 120 extend from near an outerdiameter of the insertion end 106 toward the longitudinal central axis118 to suspend the flange member 114 over the main aperture 112. ThoughFIG. 1 shows an example system with three stanchion portions 120, inother cases as few as two stanchion portions 120 may be used (e.g.,disposed on opposite sides of the flange portion 114), or greater thanthree stanchion portions may be used (e.g., four or more).

The flange member 114 and stanchion portions 120 protrude outwardly fromthe main aperture 112. Moreover, in some example systems, and as shown,the main aperture 112 is formed in a basin-like area such that there isan interior volume 122 defined between the flange member 114 and thepolymeric material defining the main aperture 112. Rather than being asealed interior volume, however, the interior volume 122 is vented toatmospheric pressure by way of openings defined between the stanchionportions 120. In particular, in the example system three vent openings124A, 124B, 124C are defined by the stanchion portions 120. Duringcertain portions of use of the system 100 the flange portion 114 maycollapse toward the main aperture 112, and in some cases the bottom sideof the flange member 114 may abut the polymeric material that forms themain aperture 112. At least some of the air displaced by the collapse ofthe flange member 114 toward the main aperture 112 may escape theinterior volume 122 through the vent openings 124. Likewise, air thatflows back in as the flange member 114 is pulled away from the mainaperture 112 flows through the vent openings 124. By comparison, airdisplaced from the main passageway, such as by insertion of the penisinto the main aperture 112, moves along the main passageway and vents atthe outer cover 104 at or near the lid 110 on the vent end. Likewise,air the flows back in the main passageway, such as during withdrawal ofthe penis out of the main passageway, moves in through the outer cover104 at or near the lid 110 and then along the main passageway.

FIG. 2 shows a cross-sectional elevation view of the system 100 of FIG.1, taken substantially along line 2-2 of FIG. 1. In particular, FIG. 2shows a portion of the outer cover 104 and the polymeric sleeve 102. Theouter cover 104 defines an internal volume 200 as well as thelongitudinal central axis 118. The polymeric sleeve 102 is partiallydisposed within the internal volume 200, and in the example systemshown, the insertion end 106 resides at least partially outside theinternal volume 200 of the outer cover 104. The polymeric sleeve 102defines an elongate body 202 and a vent end 204 opposite the insertionend 106. In some example systems, the overall length L is at least twotimes the diameter D1, but other proportions may be equivalently used.In the view of FIG. 2, the initial passageway 116 is shown, along withthe flange member 114, and stanchion portion 120. Moreover, thebasin-like structure 206 is visible, within which the main aperture 112is formed, along with the interior volume 122 and vent opening 124.

FIG. 2 further shows, in cross-sectional view, the main passageway 208.The main passageway 208 spans from the main aperture 112 on theinsertion end 106 to a vent aperture 210 on the vent end 204. In someexample systems, the main passageway 208 defines a constant internaldiameter from the main aperture 112 to the vent aperture 210; however,in other cases, and as shown, the main passageway 208 has one or morefeatures thought to enhance the stimulation characteristics. In theexample of FIG. 2, the main passageway 208 defines an increased internaldiameter annular area 212. Other features are possible, including inwardprojecting features, such as “rifling”, or various tabs or protrusions.Note, however, that the internal volume created by the annular area 212vents along the main passageway 208. That is, during insertion of thepenis, air displaced from the annular area 212 travels along the mainpassageway 208 and out the vent aperture 210. Likewise, duringwithdrawal of the penis, air drawn back in the annular area 212 willenter the vent aperture 210 and travel along the main passageway 208.

In some cases, the polymeric sleeve 102 may define an annular groove 214on an outer diameter thereof. Likewise, the outer cover 104 may define acorresponding annular ring 216 such that, when the polymeric sleeve istelescoped within the internal volume 200, the annular ring 216 maycouple within the annular groove 214. The ring/groove combination mayhelp hold the polymeric sleeve 102 in place during use, and inparticular the ring/groove combination may reduce reciprocatory movementof the polymeric sleeve during use of the device 100.

In one example system, such as shown in FIGS. 1 and 2, the diameter D1may be about three inches, the diameter D2 may be about 2.25 inches, andthe length L may be about nine inches. The thickness T of the flangemember 114 may be about 0.5 inches, but a thicker flange member may bemolded if the durometer rating of the cured polymeric material is lower.Likewise, a thinner flange member may be molded if the durometer ratingof the cured polymeric material is higher. Inasmuch as the flange member114 and stanchion portion 120 are a contiguous structure, the stanchionportion 120 may likewise have a thickness of about 0.5 inches at itsthinnest portion. It follows from the example thickness of the flangemember 114 that the length of the initial passageway 116 may be about0.5 inches. The diameter D3 of the initial passageway 116 may be about0.5 inches, and likewise the diameter of the main passageway 208 at themain aperture 112 may be about 0.5 inches. In other cases, however, thediameter of the initial passageway D3 may be larger or smaller than thediameter of the main passageway 208 at the main aperture 112. Finally,the height H that the flange member 114 is suspended over the mainaperture 112 defined in the bottom of the basin-like structure 206 maybe about one inch in some embodiments. As discussed immediately below,however, additional flange members may also be present.

FIG. 3 shows a perspective, partial cut-away, view of a system 100 inaccordance with other example embodiments. In particular, the system 100comprises a polymeric sleeve 102 at least partially disposed within aninterior volume of an outer cover 104 of rigid material, such asplastic. In the view of FIG. 3, only the insertion end 106 of thepolymeric sleeve 102 is visible, as the balance of the polymeric sleeveresides within the outer cover 104. The system 100 may further comprisea cover or lid (not specifically shown) that telescopes over theinsertion end 106 and couples to the outer cover 104. Likewise, thesystem 100 may further comprise a second cap or lid (again notspecifically shown) that couples to the outer cover 104 opposite theinsertion end 106.

The insertion end 106 in the example system of FIG. 3 comprises a mainaperture which leads to a main passageway, but neither the main aperturenor the main passageway are visible in FIG. 3. Suspended over the mainaperture is a first flange member 114 that defines an initial passageway116, and also suspended over the main aperture is a second flange member314 that defines a second initial passageway 316. In the example system,the passageway 116 is coaxial with the passageway 316, and thepassageway 316 is coaxial with the main passageway. Moreover, in theexample system, the passageway 116, passageway 316, and main passagewayare coaxial with the longitudinal central axis 118 of the polymericsleeve 102. In other systems, however, the passageways 116 and 118 maybe offset from each other, as well as offset from the main passageway.

Still referring to FIG. 3, the flange member 114 is supported in theexample system by three stanchion portions 120A, 120B, and 120C, but inthe view of FIG. 3 the stanchion portion 120B has been removed toprovide better visibility to the flange member 314 below. The flangemember 314 is supported in the example system by three stanchionportions 320, though only stanchion portions 320A and 320B are visiblein FIG. 3. As with the flange member 114 and stanchion portions 120, theentire polymeric sleeve 102 (including the flange members and stanchionportions) may be created from a single molding of polymeric material,and thus while the flange member 314 and the stanchion portions 320 areseparately named for ease of discussion, the separate naming conventionshall not obviate that the separately named components are actually asingle, continuous piece of polymeric material. The stanchion portions320 extend from the basin-like-structure 206 (near an outer diameter ofthe insertion end 106) toward the longitudinal central axis 118 tosuspend the flange member 314 over the main aperture. In the examplesystem of FIG. 3, the stanchion portions 320 are radially aligned withthe stanchion portions 120; however, radial alignment is not required,and in other cases the radial direction in which the stanchion portions320 extend may be different, and in some cases non-overlapping with theradial direction in which the stanchion portions 120 extend.

As with the flange member 114, the flange portion 314 may both collapseor translate toward the main aperture during certain portions of use,and may also be stretched away from the main aperture during otherportions of use. Though three stanchion portions 320 are discussed inreference to FIG. 3, in other cases as few as two stanchion portions 320may be used (e.g., disposed on opposite sides of the flange portion314), or greater than three stanchion portions may be used (e.g., fouror more). Moreover, the number of stanchion portions 320 need not be thesame as the number of stanchion portions 120. For example, operablesystems may comprise three stanchion portions 120 and two stanchionportions 320, or vice-versa.

The flange member 314 and stanchion portions 320 may protrude outwardfrom the main aperture 112, or as shown the upper surfaces of the flangemember 314 and stanchion portions 320 may define and reside within aplane. Moreover, the interior volume 122 defined between the flangemember 114 and the basin-like structure 206 may be bifurcated by theflange member 314 and stanchion portions 320. The portion of theinterior volume 122 defined between the basin-like structure 206 and theflange member 314 may be vented to atmospheric pressure by way of threevent openings 324 (only vent openings 324A and 324B are visible in FIG.3), which vent openings are defined by the stanchion portions 320.During certain portions of use of the system 100, the flange member 314may collapse toward the main aperture, and in some cases the bottom sideof the flange member 314 may abut the basin-like structure 206. At leastsome of the air displaced by the collapse of the flange member 314toward the main aperture may escape the interior volume 122 through thevent openings 324 (and 124). Likewise, air that flows back in as theflange member 314 is pulled away from the main aperture flows throughthe vent openings 324 (and 124).

FIG. 4 shows a cross-sectional elevation view of the system 100 of FIG.3, taken substantially along line 4-4 of FIG. 3. In particular, FIG. 4shows a portion of the outer cover 104 and the polymeric sleeve 102. Asbefore, the outer cover 104 defines an internal volume 200 as well asthe longitudinal central axis 118. The polymeric sleeve 102 is partiallydisposed within the internal volume 200, and in the example system shownthe insertion end 106 resides at least partially outside the internalvolume 200 of the outer cover 104. The polymeric sleeve 102 defines anelongate body 202 and a vent end 204 opposite the insertion end 106. Insome example systems, the overall length L is at least two times thediameter D1, but other proportions may be equivalently used. In the viewof FIG. 4, the initial passageway 116 is shown, along with the flangemember 114, and stanchion portion 120. Moreover, the basin-likestructure 206 is visible, within which the main aperture 112 is formed,along with the interior volume 122 and vent opening 124.

FIG. 4 further shows the passageway 316, along with the flange member314, and stanchion portion 320. The flange member 314 is disposedbetween the first flange member 114 and the main aperture 112 within theinterior volume 122. Moreover, the flange member 314 and stanchionportions 320 bifurcate the interior volume 122 into an anterior volume400 (between the flange member 114 and the flange member 314) and aposterior volume 402 (between the flange member 314 and the mainaperture 112). Also visible in FIG. 4 is the vent opening 324. Theremaining portions of the polymeric sleeve (e.g., the main passageway208) may be the same as discussed with respect to FIG. 2, and thus thediscussion will not be repeated here.

In the example system of FIG. 4, the vent openings 124 vent the anteriorvolume 400 to atmospheric pressure. The vent openings 324 likewise ventthe posterior volume 402 to atmospheric pressure. In the case of FIG. 4,the posterior volume 402 vents through the anterior volume 400, but inother cases a separate flow path to a point outside the polymeric sleeve102 could be used.

In one example system, such as shown in FIGS. 3 and 4, the variousdiameters, thicknesses and lengths discussed with respect to FIG. 2likewise apply. The thickness T of the flange member 314 may be about0.5 inches, but a thicker flange member may be molded if the durometerrating of the cured polymeric material is lower. Likewise, a thinnerflange member may be molded if the durometer rating of the curedpolymeric material is higher. Inasmuch as the flange member 314 andstanchion portion 320 are a contiguous structure, the stanchion portion320 may likewise have a thickness of about 0.5 inches at its thinnestportion. While the flange member 114 and flange member 314 are discussedto have the same thicknesses, in other cases the thicknesses may vary asbetween the flange members. It follows from the example thickness of theflange member 314 that the length of the second initial passageway 316may be about 0.5 inch. The diameter D4 of the passageway 316 may beabout 0.5 inch, but in other cases the diameter of the passageways maybe larger or smaller than each other, and larger or smaller than thediameter of the main passageway 208 at the main aperture 112. The heightH1 that the flange member 114 is suspended over the flange member 314(measured from the underside of the flange member 114 to the top side ofthe flange member 314) may be about 0.5 inch in some embodiments.Moreover, the height H2 that the flange member 314 is suspended overbottom portion of the basin-like structure 206 (measured from theunderside of the flange member 314 to the top side of the basin-likestructure at or near the main aperture 112) may be about 0.5 inch insome embodiments.

The specification now turns to example methods of creating the polymericsleeves. FIG. 5 shows a perspective view of a mold system 500 inaccordance with at least some embodiments. In particular, FIG. 5 showsan outer mold assembly 502 comprising first mold member 504 and secondmold member 506. Each mold member 504 and 506 defines an interiorsurface, but in the view of FIG. 5 only the interior surface 508 of moldmember 506 is visible. The interior surface 508 of mold member 506 formshalf a negative image of the exterior surface of the polymeric sleeve102 spanning from the annular groove 214 to the vent end 204. Likewise,the interior surface of the mold member 504 forms the other half of thenegative image of the exterior surface of the polymeric sleeve 102 fromthe annular groove 214 to the vent end 204.

The mold system 500 further comprises a lower mold component 510 placedin operational relationship to the interior surfaces defined by theouter mold assembly 502. The lower mold component structurally defines anegative image of the outer portions of the insertion end 106 of thepolymeric sleeve 102. An example lower mold component 510 is discussedin greater detail with respect to FIG. 6. Suffice it to say, for now,that the lower mold component 510 defines a negative image of at least aportion of the flange member 114 and stanchions 120. In some examplesystems, the various mold components, lower mold component, and diskmembers (discussed more below) may be milled from metallic material,such as aluminum. However, other materials (e.g., high density plastics)may also be used. Stacked on the lower mold component 510 is a diskmember 512. In systems having only a single interior volume 122, thedisk member 512 defines a negative image of the interior volume (e.g.,FIGS. 1 and 2). Stated otherwise, during the injection molding processthe disk member 512 resides within a volume such that no polymericmaterial may fill and/or occupy the volume, and thus the single interiorvolume is created based on presence of the disk member 512 during theinjection and curing process. In systems having only a single interiorvolume, the disk member 512 couples to a rod member 514. An exteriorsurface of the rod member 514 defines the negative image of the interiorsurface of the main passageway through the polymeric sleeve.

In systems defining both an anterior volume and a posterior volume(e.g., FIGS. 3 and 4), stacked on the disk member 512 is another diskmember 516. The disk member 516 defines a negative image of theposterior volume. Stated otherwise, during the injecting molding processthe disk member 516 resides within a volume such that no polymericmaterial may fill and/or occupy the volume, thus creating the posteriorvolume based on presence of the disk member 516 during the injection andcuring process. In systems having both the anterior and posteriorvolumes, the rod member 514 couples to the disk member 516, with the rodmember 514 again creating the main passageway in the injection moldingprocess.

The molding process may involve stacking the various disks in the lowermold component, and coupling the rod member 514 to the upper-most diskmember 512 or 516. The outer mold assembly 502 is closed around thevarious components and held in place in some fashion. The polymericmaterial in liquid form is injected through an injection port into thevolume defined by the interior surface 508, such as injection throughinjection aperture 518. The polymeric material in liquid form fills thevolume defined by the interior surface 508, displacing the air, and thenthe polymeric material is allowed to cure. Once cured, the outer moldassembly 502 is again opened, the rod member 514 withdrawn from the mainpassageway, the disk member 512 is removed from its respective volume(e.g., interior volume 122, or anterior volume 400), and if used thedisk member 516 removed from the posterior volume 400. Either before orafter removing the rod member and disk member(s), the polymeric sleeve102 may be removed from the lower mold component 510. Trimming of thepolymeric sleeve 102 may be performed, such as to remove the polymericmaterial that cured inside the injection aperture, and any mold seams ormarks formed by the interface of the outer mold assembly. In some cases,the polymeric sleeve 102 created may be treated with compound to reducesurface tension (such as by application of talcum powder). Thespecification now turns to a more detailed description of example lowermold component and example disk members.

FIG. 6 shows a perspective view of a lower mold component in accordancewith an example system, where the lower mold component may be used tocreate an insertion end 106 of a polymeric sleeve similar to those shownin FIGS. 1 and 3. In particular, the lower mold component 510 defines anexterior surface 600 and a mold surface 602 defined on an interiorsurface of the lower mold component 510. In the example lower moldcomponent 510 of FIG. 6, the mold surface 602 defines three channels604A, 604B, and 604C. The channels 604 extend from the largest insidediameter of the lower mold component 510 to a central area 608. Definedwithin the central area 608 is a protrusion or butte 610, which butte610 may be centered within the mold surface 602 along the longitudinalcentral axis 612.

The mold surface 602 of the lower mold component 510 defines a negativeimage of the outer-most portions of the insertion-end 106 of thepolymeric sleeve 102. For example, the channels 604 are the negativeimage of the stanchion portions 120. The central area 608 is thenegative image of the flange member 114. The butte 610 is the negativeimage of at least a portion of the initial passageway 116. Statedotherwise, during the injection molding process the polymeric material,in liquid form, is forced into the channels 604 and central area 608.After curing of the polymeric material, the polymeric sleeve may beremoved from the lower mold assembly 510, and thus the outer surface ofthe insertion end 106 of the polymeric sleeve 102 is formed.

Still referring to FIG. 6, a few additional features are discussed as aprecursor to discussion of the first disk member. In particular, in somecases a particular rotational alignment of the first disk member withthe lower mold component 510 is used, and thus the lower mold component510 may have one or more features that assist in the alignment process.For example, the lower mold component 510 of FIG. 6 has an alignmentfeature 614 defined in butte 610. The example alignment feature 614 isan aperture defining a triangular cross-section, though othercross-sectional shapes may be used (e.g., square, rectangle, hexagon). Acorresponding feature of the first disk member (discussed more below)has a shape that telescopes into the example alignment feature, thusensuring proper rotational alignment. In other example cases, the lowermold component 510 may define a dimple feature 616 at any convenientlocation, and as shown in shoulder region 618. The dimple feature asshown is a concave dimple or divot into the material of the lower moldcomponent 510, but convex features are likewise contemplated. The firstdisk member may have a corresponding feature (e.g., a convex feature ifdimple feature 616 is concave, or a concave feature of dimple feature616 is convex).

Finally, the example lower mold component 510 of FIG. 6 defines a seriesof shoulder regions. Shoulder region 618 was discussed with respect todimple feature 616, but additional shoulder regions 620 and 622 are alsopresent. Shoulder regions are formed, in part, by creation of thechannels 604. The shoulder regions 618, 620, and 622 may also becreated, in part, by milling or otherwise removing portions of the lowermold component 510 to form the corner regions, such as corner 624.However, in other cases the lower mold component may define a moresmoothly varying shoulder region between the central area 608 and theinside diameter of the lower mold component 510, such as illustrated bydashed line 626. The specification now turns to the first disk member.

FIG. 7 shows a perspective view of an upper portion of the disk member512. In particular, disk member 512 is configured to telescope into andabut a portion of the mold surface 602 defined by the lower moldcomponent 510. In the view of FIG. 7, the disk member 512 defines threechannels 700A, 700B, and 700C on a lower surface of the disk member 512(however, only channels 700B and 700C are visible in view of FIG. 7).When the disk member 512 is in the abutting configuration with the lowermold component 510, the channels 700 are aligned with the channels 604of the lower mold component 510, and the channels define respectivepassageways from the central area 608 to the inside diameter of thelower mold component 510. There are additional features defined on theupper portion of the disk member 512, but a discussion of thoseadditional features is presented after discussion of the features thatabut or interact with the lower mold component 510.

FIG. 8 shows a perspective view of a lower portion of the disk member512. In the view of FIG. 8, all three channels 700A, 700B, and 700C arevisible. Moreover, the disk member 512 defines a central area 808 thatcorresponds to the central area 608 of the lower mold component 510(i.e., the central area 808 and central area 608 have the same insidediameter). Also defined with the central area 800 is a protrusion orbutte 810, which butte 810 may be centered along the longitudinalcentral axis 812, and further which butte 810 defines an alignmentfeature 814, illustrative shown as a triangular feature. Also visible inthe view of FIG. 8 is an alternate alignment feature in the form adimple feature 816, illustratively shown as a protruding out of the diskmember 512.

Referring simultaneously to FIGS. 7 and 8, when the disk member 512 isin the abutting configuration with the lower mold component 510 (notshown in FIG. 7 or 8), the central axis 812 is coaxial with the centralaxis 612 of the lower mold component 510. Further, central area 808 ofthe first disk member 512 aligns with the central area 608 in the lowermold component. The central areas thus define a negative image of theflange member 114. Moreover, when the disk member 512 is in the abuttingconfiguration with the lower mold component 510, the channels 700 arealigned with the channels 604 of the lower mold component 510, and thechannels define respective passageways from the central area 800/608 tothe inside diameter of the lower mold component 510. Stated otherwise,the channels define negative images of the stanchions 120. Furtherstill, in the abutting configuration, the example alignment feature 814of the disk member 512 telescopes into the alignment feature 614 definedin the butte 610 of the lower mold component 510, thus ensuring properrotational alignment between the disk member 512 and the lower moldcomponent 510. Moreover, in the abutting configuration of the diskmember 512 with the lower mold component 510 the buttes 610/810 alignand abut to define the negative image of the initial passageway 116.During the injection molding process the polymeric material in liquidform is forced into the channels and central area. After curing of thepolymeric material, the polymeric sleeve may be removed from the lowermold component 510, the disk member 512 removed from beneath the flangemember 114, and thus the flange member 114 and stanchion portions 120 ofthe polymeric sleeve 102 are formed.

Referring again to FIG. 7, a few additional features are discussed as aprecursor to discussion of the second disk member 516. In particular,the disk member 512 defines a central area 708 on the upper portion.Also defined within the central area 708 is a protrusion or butte 710,which butte 710 may be centered along the longitudinal central axis 812,and further which butte 710 defines an alignment feature 714,illustrative shown as a triangular feature. A corresponding feature ofthe second disk member (discussed more below) has a shape thattelescopes into the example alignment feature, thus ensuring properrotational alignment. The location of the “male” alignment feature andthe “female” alignment feature associated with the buttes may beequivalently reversed. Moreover, other alignment features may be used,such as dimple features as shown with respect to the lower moldcomponent 510 and underside of the first disk member 512, but thevarious dimple features are not shown on the upper surface of the firstdisk member 512 (i.e., the view of FIG. 7) so as not to furthercomplicate the drawings. The upper portion of the disk member 512 inFIG. 7 further shows a channels 702A, 702B, and 702C, wherein thechannels extend from the central area 708 radially outward. In theexample shown, the channels 702 align with the channels 700, but suchalignment is not strictly required.

Finally, the example lower disk member 512 of FIG. 7 defines a series oflower shoulder regions 718, 720 and 722, which shoulder regions abutrespective shoulder regions 618, 620, and 622 of the lower moldcomponent 510 when the disk member 512 is stacked into an abuttingrelationship with the lower mold component 510. However, in other casesthe lower mold component may define a more smoothly varying shoulderregion, and thus the shoulder regions may be more smoothly varying (asshown by dashed line 726). The specification now turns to the seconddisk member.

FIG. 9 shows a perspective view of an upper portion of the second diskmember 516. In particular, disk member 516 is configured to stack intothe lower mold component and abut a portion of the first disk member512. In the view of FIG. 9, the second disk member 516 defines threechannels 900A, 900B, and 900C on the underside (however, only channels900B and 900C are visible in view of FIG. 9). When the second diskmember 516 is in the abutting configuration with the first disk member512, the channels 900 align with the channels 702 on the upper surfaceof the first disk member 512, and the channels define respectivepassageways from the central area 708 radially toward the insidediameter of the lower mold component 510. There are additional featuresdefined on the upper portion of the disk member 516, but a discussion ofthose additional features is presented after discussion of the featuresthat abut or interact with the first disk member 512.

FIG. 10 shows a perspective view of a bottom side of the disk member516. In the view of FIG. 10, all three channels 900A, 900B, and 900C arevisible. Moreover, the disk member 516 defines a central area 1008 thatcorresponds to the central area 708 of the first disk member 512 (i.e.,the central area 1008 and central area 708 have the same insidediameter). Also defined with the central area 1008 is a protrusion orbutte 1010, which butte 1010 may be centered along the longitudinalcentral axis 1012, and further which butte 1010 defines an alignmentfeature 1014, illustrative shown as a triangular feature. Otheralignment features (such as the dimple features) may be used torotationally align the second disk 516 and the first disk 512. However,those dimple features are not shown in FIGS. 9 and 10 so as not tofurther complicate the figures.

Referring simultaneously to FIGS. 9 and 10, when the second disk member516 is in the abutting configuration with the first disk member 512, thecentral axis 1012 is coaxial with the central axis 812 of the first diskmember 512. Further, central area 1008 of the second disk member 516aligns with the central area 708 in the second disk member 512. Thecentral areas thus define a negative image of the flange member 314.Moreover, when the disk member 516 is in the abutting configuration withthe first disk member 512, the channels 900 are aligned with thechannels 702 of the second disk member, and the channels definerespective passageways from the central area 1008/708 toward the insidediameter of the lower mold component 510. Stated otherwise, the channelsdefine negative image of the stanchions 320. Further still, in theabutting configuration the example alignment feature 1014 of the seconddisk member 516 telescopes into the alignment feature 714 defined in thebutte 710 of the first disk member 512, thus ensuring proper rotationalalignment between the first disk member 516 and the second disk member512. The location of the “male” alignment feature and the “female”alignment feature associated with the buttes may be equivalentlyreversed. Moreover, in the abutting configuration of the second diskmember 516 with the first disk member 512 the buttes 1010/710 align andabut to define the negative image of the second initial passageway 316.During the injection molding process the polymeric material in liquidform is forced into the channels and central area. After curing of thepolymeric material, the polymeric sleeve may be removed from the lowermold assembly 510, the disk member 512 removed from beneath the flangemember 114, the disk member 516 removed from beneath the flange member314, and thus the flange members 114, 314 and stanchion portions 120,320 of the polymeric sleeve 102 are formed.

Referring again to FIG. 9, a few additional features are discussed. Theupper portion of the second disk member 516 defines a protrusion orbutte 1016, which butte 1016 may be centered along the longitudinalcentral axis 812. During stacking of the various components into thelower mold component 510, once the second disk member 516 is in place,the rod member 514 may couple to the butte 1016. Thus, the butte 1016forms the negative image of the main aperture 112 into the elongate body202.

FIG. 11 shows a perspective view of the various components that form theinsertion end of the polymeric sleeve 102 stacked together in anabutting relationship (i.e., the mold system 1100). In particular, thelower mold component 510 is shown. Stacked within the lower moldcomponent 510 is the first disk member 512. Stacked on top of the firstdisk member 512 is the second disk member 516. For the example system,notice how all the various channels align. As discussed above, thechannels in the mold system form the stanchions that support the variousflange members, and the central areas (none of which are visible in FIG.11) form the flange members.

FIG. 12 shows a cross-sectional, elevation view of the mold system 1100of FIG. 11 taken substantially along lines 12-12 of FIG. 11. Inparticular, shown in FIG. 12 is the lower mold component 510, includingthe central area 608, butte 610, and channel 604. Further, the firstdisk member 512 is shown in a stacked and abutting relationship with thelower mold component 510. For example, the butte 810 is shown abuttingthe butte 610, and shoulder region 1200 of the first disk member 512(which shoulder area 1200 could be any of the shoulder regions 718, 720,and 722) is shown abutting shoulder area 1202 of the lower moldcomponent 510 (which shoulder area 1202 could be any of the should areas618, 620, 622). Moreover, central area 808 is shown, along with channel700.

FIG. 12 further shows the second disk member 516 in a stacked andabutting relationship with the first disk member 516. For example, thebutte 710 is shown abutting the butte 1010. Moreover, central areas 708and 1008 are shown, along with channels 702 and 900. Finally, butte 1016is shown. In the stacked configuration, the central axis of eachindividual components are coaxial, as shown by dashed line 1204.

The insertion end 116 shown in FIG. 1 is merely an example. Nowunderstanding how to create such an insertion end using an injectionmolding process based on reading this specification, one of ordinaryskill in the art could see that many variations in the outwardappearance of the insertion end 116 could be made without departing fromthe scope and spirit of the various embodiments. For example, FIG. 13shows a perspective view of an example insertion end 116 in accordancewith other systems. In the example system, the stanchion portions 1320extend from the outer perimeter of the insertion end 116 to the flangemember 114, but in this case the stanchion portions are curved or archedsuch that the cardinal orientation of the location where each stanchionportion 1320 intersects the outer perimeter is different than thecardinal orientation where the stanchion portion 1320 intersects theflange member 114. For example, if the arrow 1350 represents a zerodegree cardinal direction in relation to the insertion end 116, theintersection location 1352 where stanchion portion 1320A meets theflange member 114 may be considered to be at the zero degree cardinaldirection, but the corresponding location 1354 where the stanchionportion 1320A meets the outer perimeter may be shifted between 10 and 45degrees (in this case, clockwise when viewing the insertion end 116 fromthe view of FIG. 13). The corresponding locations 1356 and 1358 maylikewise be shifted between 10 and 45 degrees. Some or all thestanchions portions may have the cardinal direction shift.

The “swirl” pattern of the insertion end 116 in FIG. 13 may result in anoperational characteristic not present in other cases (such as FIG. 1).In particular, as mentioned above, during insertion of the penis intothe aperture 116 the flange member tends to collapse toward the mainaperture 112. However, during withdrawal of the penis, the flange member114 tends to be not only pulled away from the main aperture 112, butalso pulled further away from the main aperture than the restingposition (shown in FIG. 13). The shifting in cardinal direction of theintersection locations of the stanchions portions between the flangemember 114 and outer perimeter may result in a rotational aspect duringwithdrawal of the penis. In particular, during withdrawal, as thestanchion portions 1320 stretch, the offset in cardinal orientation mayresult in a rotational movement of the flange portion 114, therotational movement illustrated by arrow 1360. The rotational movementis cause by the tangential component of the tension placed on the flangemember 114 during periods when the flange member is stretched away fromthe (un-stretched) rest orientation (i.e., during withdrawal of thepenis). As the tension in the stanchion portions is released, the lossof the tangential component of the tension may enable the flange member114 to rotate back to its rest configuration (the rotation shown byarrow 1362).

Although several parameters of the example systems affect thestimulation provided by the polymeric sleeve 102 (e.g., elasticity ofthe polymeric material, diameter of the apertures defining thepassageways, etc.), the various embodiments comprising at least oneflange member are believed to better simulate the physical feel offellatio.

FIG. 14 shows, in block diagram form, a method in accordance with atleast some embodiments. In particular, the method starts (block 1400)and comprises: placing a lower mold component, the lower mold componentstructurally defines a negative image an insertion end of a polymericsleeve (block 1402); stacking into mating relationship a first diskmember, the first disk member structural defines a negative image of ananterior volume vented to atmosphere on the insertion end of thepolymeric sleeve (block 1404); stacking a second disk member into matingrelationship with the first disk member, the second disk memberstructural defines a negative image of a posterior volume vented toatmospheric pressure (block 1406); coupling a rod member to the diskmembers, an exterior surface of the rod member defines a negative imageof a main passageway through the polymeric sleeve (block 1408); closingan outer mold assembly around the lower mold component, the disk member,and the rod member, an interior surface of the outer mold assemblystructurally defines a negative image of an outer surface of thepolymeric sleeve (block 1410); and injecting a polymeric compound in aliquid state into the outer mold assembly (block 1412). Thereafter, themethod ends (block 1414), likely to be repeated again with the same moldassembly.

References to “one embodiment,” “an embodiment,” “some embodiments,”“example embodiments,” or the like indicate that a particular element orcharacteristic is included in at least one embodiment of the invention.Although the phrases may appear in various places, the phrases do notnecessarily refer to the same embodiment.

The above discussion is meant to be illustrative of the principles andvarious embodiments of the present invention. Numerous variations andmodifications will become apparent to those skilled in the art once theabove disclosure is fully appreciated. For example, an outer cover isnot strictly required to use the polymeric sleeve. It is intended thatthe following claims be interpreted to embrace all such variations andmodifications.

What is claimed is:
 1. A system comprising: a polymeric sleevecomprising: an elongate body that defines a first end, a second endopposite the first end, and a longitudinal central axis; a mainpassageway through the elongate body parallel to the central axis, themain passageway extends from the first end to the second end, and themain passageway defines a first aperture on the first end and a secondaperture on the second end; a first member suspended over the firstaperture on the first end, the first member defines a first initialpassageway parallel to the main passageway, and the first member andfirst end define an interior volume; and a first vent opening defined inpart by the first member, the first vent opening distinct from thepassageways, and the first vent opening fluidly couples the interiorvolume to atmosphere pressure.
 2. The system of claim 1 wherein the mainpassageway is coaxial with the longitudinal central axis of the elongatebody.
 3. The system of claim 1 wherein the first initial passageway iscoaxial with the main passageway.
 4. The system of claim 1 wherein thepolymeric sleeve further comprises: a second member suspended betweenthe first member and the first aperture in the interior volume, thesecond member defining a second initial passageway parallel to the mainpassageway, and the second member bifurcates the interior volume into ananterior volume and a posterior volume; and a second vent openingdefined in part by the second member, the second vent opening distinctfrom the passageways, and the second vent opening fluidly couples theposterior volume to atmospheric pressure.
 5. The system of claim 4further comprising the second vent opening fluidly couples the posteriorvolume to the anterior volume.
 6. The system of claim 4 furthercomprising at least one selected from the group consisting of: thesecond initial passageway is coaxial with the first initial passageway;the second initial passageway is coaxial with the main passageway; andthe passageways are coaxial.
 7. The system of claim 1 further comprisingan outer cover of rigid material that defines an interior volume,wherein the elongate body is at least partially disposed within theouter cover.
 8. A system comprising: an outer cover of rigid material,the outer cover defines an interior volume; a polymeric sleeve at leastpartially disposed in the interior volume of the outer cover, thepolymeric sleeve comprising: an elongate body that defines a first end,a second end opposite the first end, and a longitudinal central axis; amain passageway through the elongate body parallel to the central axis,the main passageway extends from the first end to the second end, andthe main passageway defines a first aperture on the first end and asecond aperture on the second end; a first member suspended over thefirst aperture on the first end, the first member defines a firstinitial passageway parallel to the main passageway, and the first memberand first end define an interior volume; and a first vent openingdefined in part by the first member, the first vent opening distinctfrom the passageways, and the first vent opening fluidly couples theinterior volume to atmosphere pressure; wherein the first member residesoutside the interior volume of the outer cover.
 9. The system of claim 8wherein the main passageway is coaxial with the longitudinal centralaxis of the elongate body.
 10. The system of claim 8 wherein the firstinitial passageway is coaxial with the main passageway.
 11. The systemof claim 8 wherein the polymeric sleeve further comprises: a secondmember suspended between the first member and the first aperture in theinterior volume, the second member defining a second initial passagewayparallel to the main passageway, and the second member bifurcates theinterior volume into an anterior volume and a posterior volume; and asecond vent opening defined in part by the second member, the secondvent opening distinct from the passageways, and the second vent openingfluidly couples the posterior volume to atmospheric pressure.
 12. Thesystem of claim 11 further comprising the second vent opening fluidlycouples the posterior volume to the anterior volume.
 13. The system ofclaim 11 further comprising at least one selected from the groupconsisting of: the second initial passageway is coaxial with the firstinitial passageway; the second initial passageway is coaxial with themain passageway; and the passageways are coaxial.
 14. The system ofclaim 8 wherein the second end of the elongate body resides within theinterior volume of the outer cover.
 15. The system of claim 8 furthercomprising: a first cap member configured to telescope over the firstmember and removably couple the outer cover; and a second cap memberconfigured to removably couple to the outer cover opposite the first capmember.
 16. A method of making a polymeric sleeve comprising: placing alower mold component, the lower mold component structurally defines anegative image an insertion end of a polymeric sleeve; stacking intomating relationship a first disk member, the first disk memberstructural defines a negative image of an anterior volume vented toatmosphere on the insertion end of the polymeric sleeve; coupling a rodmember to the disk member, an exterior surface of the rod member definesa negative image of a main passageway through the polymeric sleeve;closing an outer mold assembly around the rod member, an interiorsurface of the outer mold assembly structurally defines a negative imageof an outer surface of the polymeric sleeve; and injecting a polymericcompound in a liquid state into the outer mold assembly.
 17. The methodof claim 16 further comprising, prior to coupling the rod member,closing the outer mold assembly, and injecting: stacking a second diskmember into mating relationship with the first disk member, the seconddisk member structural defines a negative image of a posterior volumevented to atmospheric pressure.
 18. The method of claim 17 furthercomprising: wherein placing the lower mold component further comprisesplacing the lower mold component comprising at least two channels thatstructurally define, in part, a negative image of a first set ofstanchions coupled of the polymeric sleeve; and wherein placing thesecond disk member further comprises placing the second disk membercomprising at least two channels that structurally define, in part, anegative image of a second set of stanchions coupled of the polymericsleeve.
 19. The method of claim 16 wherein placing the lower moldcomponent further comprising placing the lower mold component comprisingat least two channels that structurally define a negative image ofstanchions coupled of the polymeric sleeve.
 20. A mold system forcreating a polymeric sleeve, the mold system comprising: a lower moldcomponent that defines an exterior surface and a mold surface, the moldsurface defines two channels, each channel extending from an insidediameter of the lower mold component to a first central area; a firstdisk member configured to abut the mold surface of the lower moldassembly, the first disk member defines two channels, and in theabutting configuration the channels of the first disk member are alignedwith the channels of the lower mold component and define respectivepassageways from the central area to the inside diameter.
 21. The moldsystem of claim 20 further comprising: a first feature defined by themold surface of the lower mold assembly; and a second feature defined byan abutting surface of the first disk member; wherein the first featureand second feature align when the first disk member is in correctabutting relationship with the lower mold assembly.
 22. The mold systemof claim 20 further comprising: a second disk member configured to abutthe first disk member opposite the abutting relationship of the firstdisk member to the mold surface, the second disk member defines twochannels, and in the abutting configuration the two channels of thesecond disk member define respective passageways from a second centralarea toward the inside diameter of the lower mold assembly.
 23. The moldsystem of claim 22 wherein the two channels of the second disk memberdefine respective passageways from the second central area to the insidediameter of the lower mold assembly.
 24. The mold system of claim 22further comprising: a third feature defined by a second surface of thefirst disk member, the second surface oppose a first surface that abutsthe mold surface of the lower mold assembly; and a fourth featuredefined by an abutting surface of the second disk member; wherein thethird feature and fourth feature align when the second disk member is incorrect abutting relationship with the first disk member.
 25. The moldsystem of claim 20 further comprising: wherein the lower mold assemblydefines three channels in the mold surface, the channels extendingradially outward from the first central area; and wherein the first diskmember defines a three channels extending radially outward from thesecond central area, and in the abutting configuration the channels ofthe first disk member are aligned with the channels of the lower moldassembly and define respective passageways from the central area to theinside diameter.
 26. The mold assembly of claim 20 further comprising: afirst protrusion defined in the first central area, the first protrusionextending toward the first disk member when the first disk member is inthe abutting relationship; a second protrusion defined by the first diskmember, the second protrusion abutting the first protrusion and creatinga pillar when the first disk member is in the abutting relationship withthe lower mold assembly.